Health TrialsbyHealthPanel

Safety and Efficacy Study of A Viscoelastic-free Method for Implantable Collamer Lens (ICL) Implantation

ConditionMyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorWenzhou Medical University

About this trial

This study evaluates the safety and efficacy of a viscoelastic-free method for Implantable Collamer Lens(ICL) implantation to treat high myopia. The subjects undergo randomization of ICL implantation using the viscoelastic-free method on one eye and undergoing standard method on the other one. The post-operative data are collected for analysis.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Documented stable refraction for at least 1 year(within 0.5D)

Best spectacle-corrected visual acuity (BCVA) of 20/40 or better

Clear central cornea

-0.5D to -18.0D of myopic refractive error

Disqualifiers

Preexisting ocular diseases or conditions other than myopia, evidence of progressive or acute ocular disease

Evidence of connective tissue disease or other systemic diseases that may confound the results of the study;

Narrow angle of anterior chamber

Pregnant, lactating, or planning to become pregnant during the course of the trial

Trial design

Design model

Single group

Treatments tested in this trial

  • viscoelastic-free implantation system

    Device

    Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation

  • standard viscoelastic-assisted Implantation system

    Device

    This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: viscoelastic-free systemExperimental treatment 1 intervention
Group B: viscoelastic-assisted systemActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Early Post-operative Intraocular Pressure

Intraocular Pressure measured by non-contact tonometers

Time frame
2 hours after surgery

Secondary outcomes

1

Corrected Visual Acuity (UCVA) at Distance

Subjective refraction

Time frame
baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
2

Uncorrected Visual Acuity (UCVA) at Distance

Measure by visual acuity chart

Time frame
baseline, 1 day, 1 week, 1 month, 3 months and 6 months after surgery
3

Endothelial Cell Density

Measure by Specular Microscope

Time frame
baseline, 1 month, 3 months and 6 months after surgery
4

Vault measured by anterior segment OCT

Vault measured by anterior segment OCT

Time frame
2 hours, 1 day, 1 week, 1 month, 3 months and 6 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wenzhou Medical University

Lead sponsor

Source ClinicalTrials.gov
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